Neuromuscular Blocking AgentsNCT06948409
NMBA Reversal and Postoperative Urinary Retention
An observational study of Neuromuscular Blocking Agents and Urinary Retention After Procedure, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
In this single-center retrospective cohort study of adult patients who underwent surgery under general anesthesia at Beth Israel Deaconess Medical Center between September 2016 and January 2024, the association between the choice of neuromuscular blocking agent (NMBA) reversal strategy, comparing sugammadex with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Blocking Agents, Urinary Retention After Procedure, Urinary Retention Postoperative
- What is being tested?
- Choice of reversal agent (sugammadex or neostigmine [with muscaranic antagonist])
- How many people
- 70,000 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Surgical patients at Beth Israel Deaconess Medical Center between September 2016 and January 2024
Who may be able to join
- Adult patients
- Non-urinary system surgery
- General anesthesia
- Use of rocuronium or vecuronium for neuromuscular blockade
- Neuromuscular blockade reversal with sugammadex or neostigmine (with atropine and/or glycopyrrolate)
- Postoperative admission to the post-anesthesia care unit (PACU)
Who cannot join
- American Society of Anesthesiologists (ASA) physical status ≥ V
- Emergency reversal with sugammadex (≥ 16 mg/kg of sugammadex)
- Presence of foley or suprapubic catheter before or after the procedure
- Prior history of bladder resection surgery
- Observations with missing data for pre-specified confounding variables
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: The Choice of Neuromuscular Blockade Reversal Agent and Its Effects on Postoperative Urinary Retention: A Retrospective Cohort Study
In this single-center retrospective cohort study of adult patients who underwent surgery under general anesthesia at Beth Israel Deaconess Medical Center between September 2016 and January 2024, the association between the choice of neuromuscular blocking agent (NMBA) reversal strategy, comparing sugammadex with neostigmine (combined with a muscarinic antagonist), and postoperative urinary retention (POUR) will be evaluated. In secondary analyses, the effects of NMBA reversal strategy and POUR on costs of care and unplanned hospital visits will be analyzed.
- Conditions
- Neuromuscular Blocking Agents, Urinary Retention After Procedure, Urinary Retention Postoperative, Neuromuscular Blockade Reversal Agent, Neuromuscular Blockade, Costs
- Being tested
- Choice of reversal agent (sugammadex or neostigmine [with muscaranic antagonist])
- Keywords
- Neuromuscular Blockade, Neuromuscular Blocking Agents, Sugammadex, Neuromuscular Blockade reversal agent, Urinary Retention Postoperative, Urinary Retention, Urinary Retention After Procedure, Costs, Neostigmine, Anesthesia, Atropine, Glycopyrrolate
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choice of reversal agent (sugammadex or neostigmine [with muscaranic antagonist])Drug
The use of sugammadex or neostigmine (in co-administration with muscarinic antagonist) will be compared. The muscarinic antagonists that will be considered are atropine and glycopyrrolate.
What is being measured
The primary outcome is the main question the study is designed to answer.
PACU discharge delay due to POUR
The primary outcome, post-anesthesia care unit (PACU) discharge delay due to postoperative urinary (POUR), will be defined as a documented delay in PACU discharge due to the inability to void. The PACU nurses or physicians responsible for immediate postoperative care routinely document these delays. Documentation about delays is required before a patient is discharged from the PACU. Within the individual categories "renal", "urinary", and "other", the investigators will search through all free text entries related to urinary retention. The study team will perform this review, and potential misspellings or synonyms will be identified and accounted for during the review process. The final primary endpoint, PACU discharge delay due to POUR, will be binary, and the endpoint data will be reported as frequency (total number [n] and proportion [%]).
Measured: During the admission to the PACU (Perioperative, up to day 1)
Secondary outcomes (6)
Costs of care
Costs of care will be assessed using the hospital's cost calculations from an internal financial tracking system. This endpoint will include direct hospital costs, defined as variable and fixed costs directly associated with patient-care-related activities. To maintain the sensitive nature of cost data, the investigators will match the outcome data with data from the Healthcare Cost and Utilization Project-National Inpatient Sample (HCUP-NIS). Differences in total perioperative healthcare-associated costs in US-dollars between patients receiving different reversal strategies will be reported. While direct hospital cost data from the hospital network will serve as the outcome for linear regression analyses, the HCUP-NIS only provides total hospital costs. Thus, data will be matched with the HCUP-NIS data, and regression estimates from the study's dataset will subsequently be translated to obtain changes in total costs.
Measured: During the patient's hospital stay (Through study completion, an average of 1-2 weeks)
Unplanned hospital visits
Unplanned hospital visits within 7 days after ambulatory surgery will be defined as unplanned admission to the hospital after surgery, emergency department (ED) visits, or readmission to the hospital. Only patients undergoing ambulatory procedures will be included in this analysis. International Classification of Diseases, 10th Revision, Clinical Modification diagnostic codes, and notes related to the ED or readmission will be used to define unplanned hospital visits. Only the admission directly following the ambulatory procedure will be considered. If a patient undergoes more than one ambulatory procedure within 7 days before an inpatient admission, the procedure closest to the unplanned hospital visit will be identified as the index case.
Measured: Within 7 days after surgery
Time to PACU discharge readiness
Time to PACU discharge readiness will be defined as the time from arrival to the PACU until a nurse has cleared the patient to be ready for discharge, measured in minutes. This outcome offers an accurate estimate of patient recovery independent from institutional factors such as bed availability or staffing, as opposed to the overall PACU length of stay.
Measured: During the admission to the PACU (Perioperative, up to day 1)
PACU length of stay
PACU length of stay, measured in minutes, is the time between arrival until discharge from the PACU following surgery. In contrast to PACU discharge readiness, this endpoint considers the total time a patient spent in the PACU and correlates with the use of resources used (and subsequently costs) for post-anesthetic care for a patient.
Measured: During the admission to the PACU (Perioperative, up to day 1)
Postoperative hospital length of stay
Postoperative hospital length of stay will be defined as the time between surgery and discharge during the index hospitalization, measured in days. Patients undergoing ambulatory surgery will not be considered for this analysis.
Measured: During the patient's hospital stay, defined as the time between surgery and day of discharge (Through study completion, an average of 1-2 weeks)
Urinary catheter use or straight catheterization
The use of urinary catheters or straight catheterization within 3 days after surgery will be assessed. Patients undergoing ambulatory surgery will not be considered for this analysis.
Measured: Within 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start8 Jun 2025
- Primary completion31 Aug 2025
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular Blocking AgentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca J Wachtendorf, MD, Beth Israel Deaconess Medical Center
- Investigators
- Maximilian S Schaefer, MD, PhD, Principal investigator, Center for Anesthesia Research Excellence, Beth Israel Deaconess Medical CenterLuca J Wachtendorf, MD, Principal investigator, Center for Anesthesia Research Excellence, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948409
- Sponsor's protocol ID
- 2025P000474
- Other IDs
- MISP #102761
- Status last verified
- Jan 2026
- First submitted
- 11 Apr 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to the sensitive nature of the data collected for this study, requests to access the dataset from qualified researchers trained in human subject research and confidentiality may be sent to Maximilian S. Schaefer at msschaef@bidmc.harvard.edu.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Choice of Neuromuscular Blockade Reversal Agent and Its Effects on Postoperative Urinary Retention: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06948409
- Acronym / sponsor ID
- 2025P000474
- Conditions
- Neuromuscular Blocking Agents, Urinary Retention After Procedure, Urinary Retention Postoperative, Neuromuscular Blockade Reversal Agent, Neuromuscular Blockade, Costs
- Keywords
- Neuromuscular Blockade, Neuromuscular Blocking Agents, Sugammadex, Neuromuscular Blockade reversal agent, Urinary Retention Postoperative, Urinary Retention, Urinary Retention After Procedure, Costs
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70,000 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 8 Jun 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this single-center retrospective cohort study of adult patients who underwent surgery under general anesthesia at Beth Israel Deaconess Medical Center between September 2016 and January 2024, the association between the choice of neuromuscular blocking agent (NMBA) reversal strategy, comparing sugammadex with neostigmine (combined with a muscarinic antagonist), and postoperative urinary retention (POUR) will be evaluated. In secondary analyses, the effects of NMBA reversal strategy and POUR on costs of care and unplanned hospital visits will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients at Beth Israel Deaconess Medical Center between September 2016 and January 2024
Key inclusion criteria (6 listed)
- Adult patients
- Non-urinary system surgery
- General anesthesia
- Use of rocuronium or vecuronium for neuromuscular blockade
- Neuromuscular blockade reversal with sugammadex or neostigmine (with atropine and/or glycopyrrolate)
Key exclusion criteria (5 listed)
- American Society of Anesthesiologists (ASA) physical status ≥ V
- Emergency reversal with sugammadex (≥ 16 mg/kg of sugammadex)
- Presence of foley or suprapubic catheter before or after the procedure
- Prior history of bladder resection surgery
- Observations with missing data for pre-specified confounding variables
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Choice of reversal agent (sugammadex or neostigmine [with muscaranic antagonist])The use of sugammadex or neostigmine (in co-administration with muscarinic antagonist) will be compared. The muscarinic antagonists that will be considered are atropine and glycopyrrolate. | Drug | – |
Primary outcome
PACU discharge delay due to POUR
Time frame: During the admission to the PACU (Perioperative, up to day 1)
The primary outcome, post-anesthesia care unit (PACU) discharge delay due to postoperative urinary (POUR), will be defined as a documented delay in PACU discharge due to the inability to void. The PACU nurses or physicians responsible for immediate postoperative care routinely document these delays. Documentation about delays is required before a patient is discharged from the PACU. Within the individual categories "renal", "urinary", and "other", the investigators will search through all free text entries related to urinary retention. The study team will perform this review, and potential misspellings or synonyms will be identified and accounted for during the review process. The final primary endpoint, PACU discharge delay due to POUR, will be binary, and the endpoint data will be reported as frequency (total number [n] and proportion [%]).
6 secondary outcomes
Costs of care
Time frame: During the patient's hospital stay (Through study completion, an average of 1-2 weeks)
Unplanned hospital visits
Time frame: Within 7 days after surgery
Time to PACU discharge readiness
Time frame: During the admission to the PACU (Perioperative, up to day 1)
PACU length of stay
Time frame: During the admission to the PACU (Perioperative, up to day 1)
Postoperative hospital length of stay
Time frame: During the patient's hospital stay, defined as the time between surgery and day of discharge (Through study completion, an average of 1-2 weeks)
Urinary catheter use or straight catheterization
Time frame: Within 3 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Undecided. Due to the sensitive nature of the data collected for this study, requests to access the dataset from qualified researchers trained in human subject research and confidentiality may be sent to Maximilian S. Schaefer at msschaef@bidmc.harvard.edu.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maximilian S Schaefer, MD, PhD principal investigator
Center for Anesthesia Research Excellence, Beth Israel Deaconess Medical Center
Luca J Wachtendorf, MD principal investigator
Center for Anesthesia Research Excellence, Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blocking Agents and Urinary Retention After Procedure, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PACU discharge delay due to POUR (time frame: During the admission to the PACU (Perioperative, up to day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.